Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01645020
Status:
UNKNOWN
Last Update Posted:
2012-07-19
First Post:
2012-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['absorbable mesh', 'Partially absorbed Mesh', 'Prolift', 'Prolift + M', 'mesh related complications'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '21720912', 'type': 'BACKGROUND', 'citation': 'Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011 Nov;22(11):1405-11. doi: 10.1007/s00192-011-1482-4. Epub 2011 Jul 1.'}], 'seeAlsoLinks': [{'url': 'http://www.ethicon.com/our-story/press-room/prolift_POP_launch', 'label': "GYNECARE PROLIFT+M™ was developed by Ethicon Women's Health \\& Urologyoffers. this company offers treatment solutions for a range of female pelvic health disorders."}]}, 'descriptionModule': {'briefSummary': 'Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.', 'detailedDescription': 'Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that\'s why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient\'s body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.\n\nDuring the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.\n\nA polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.\n\nThe number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women been operated at Western Galilee Hospital - Nahariya Israel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.\n\nExclusion Criteria:\n\n* Women with significant pre-operative pain\n* Women with collagen diseases\n* Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall'}, 'identificationModule': {'nctId': 'NCT01645020', 'briefTitle': 'Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures', 'orgStudyIdInfo': {'id': '20'}}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Nahariya', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'M Neuman, MD', 'role': 'CONTACT', 'email': 'mneuman@netvision.net.il', 'phone': '972 3 956 3105'}, {'name': 'R sawaid, MD', 'role': 'CONTACT', 'email': 'raneen.sawaid@gmail.com', 'phone': '972 4 956 3035'}], 'overallOfficials': [{'name': 'M Neuman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Menahem Neuman', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}